Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
Colon/Rectal Cancer
Lung Cancer
18 Years and older, Male and Female
COVALENT-102 (primary)
NCI-2023-01290
Summary
A Phase 1/1b dose finding study to determine the OBD(s) and RP2D(s) of BMF-219, a
covalent menin inhibitor small molecule, in subjects with KRAS mutated unresectable,
locally advanced, or metastatic NSCLC (Cohort 1), PDAC (Cohort 2), and CRC (Cohort 3).
Objectives
This is a dose finding study to determine the safety and tolerability, pharmacokinetics
and pharmacodynamics, and clinical activity of escalating doses of BMF-219 administered
orally (PO) either once daily (QD) or twice daily (BID) in 28-day cycles. After observing
acceptable safety performance in these dosing regimens, additional subjects will be
enrolled to assess efficacy in the determination of the OBD for use as a RP2D.
Eligibility
- Adults with a confirmed diagnosis of unresectable, locally advanced and/or metastatic Stage IIIB/IV NSCLC, Stage III/IV PDAC and/or Stage III/IV CRC with no curative-intent treatment options and documented activating KRAS mutation (without known additional actionable driver mutations such as EGFR, ALK or ROS1)
- Documented progression and measurable disease after = 1 prior line of systemic therapy (= 2 and = 4 prior lines for NSCLC) with adequate washout period and resolution of treatment-related toxicities to = Grade 2
- ECOG PS of 0-2 (0-1 for PDAC) and a life expectancy > 3 months in the opinion of the Investigator
- Adequate hematological, liver, and renal function
- Men and women of childbearing potential must use adequate birth control measures for the duration of the trial and at least 90 days after discontinuing study treatment
Treatment Sites in Georgia
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